- Design
- Multicentre, open-label, non-inferiority randomised trial
- Population
- 880 treatment-naive adults with non-cirrhotic HCV in India
- Primary outcome
- SVR12 (per protocol)
- Effect
- 98.8% vs 99.0%; risk difference 0.2% (95% CI −1.5 to 1.9)
RESOLVE was a multicentre, open-label, non-inferiority trial in five publicly funded hospitals in India, funded by the ICMR. It randomised 880 treatment-naive adults with non-cirrhotic hepatitis C mono-infection, median age 35, to sofosbuvir 400 mg plus velpatasvir 100 mg daily for 8 or 12 weeks.
Per protocol, sustained virological response at 12 weeks was 98.8% with 8 weeks and 99.0% with 12 weeks (risk difference 0.2%, 95% CI −1.5 to 1.9). On intention-to-treat analysis it was 93.5% and 91.8%. Both analyses met the 5% non-inferiority margin. No participant had a drug-related serious adverse event or stopped for side effects.
This is directly relevant to Indian practice: the population, the public-hospital setting and the regimen are those Indian clinicians treat every day. A third less treatment means lower cost and fewer visits, and in a young population lost to follow-up, possibly more people finishing. Current guidelines still list 12 weeks for this regimen, so a shift should come through national programme guidance rather than one trial, but the evidence for shortening is now strong.
- In treatment-naive, non-cirrhotic hepatitis C, 8 weeks of sofosbuvir-velpatasvir cured as many patients as 12 weeks in this trial.
- Confirm absence of cirrhosis before considering the shorter course; cirrhotic patients were excluded.
- The result applies to treatment-naive mono-infection only, not to HIV or hepatitis B co-infection.
- Check SVR12 at 12 weeks after the end of treatment, whichever duration is used.
Why it matters
Shorter courses could make hepatitis C elimination cheaper and easier to complete in India.
Don't overread it
Current guidelines have not yet changed; the label duration for this regimen remains 12 weeks.
The statistics, in plain English
Non-inferiority means the shorter course was shown to be no more than 5 percentage points worse. The confidence interval for the difference (−1.5 to 1.9 points) lies well within that margin, so any true loss of efficacy is likely to be very small.
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